Pharmag Automatic Capsule Filler
| Brand | Pharmag |
|---|---|
| Origin | Germany |
| Model | Pharmag AC-3000 |
| Throughput | 3000 capsules/hour |
| Capsule Sizes | #00, #0, #1, #2, #3, #4 |
| Power Supply | 230 V AC, 50/60 Hz, Single-phase |
| Motor | 90 W, 1400 rpm, 230 V AC, Three-phase (Gearbox Reduction Ratio: 30:1) |
| Rated Power | 0.75 kW (including vacuum pump) |
| Vacuum Pump Capacity | 6 m³/h |
| Vacuum Suction Pump Capacity | 9 m³/h |
| Air Compressor | 50 L/min at 1.5 bar |
| Contact Materials | AISI 316 stainless steel |
| Control System | PLC-based automation |
| Compliance | GMP-compliant design, CE-certified |
Overview
The Pharmag AC-3000 Automatic Capsule Filler is a precision-engineered, benchtop-scale solid dosage form manufacturing system designed for reliable, repeatable capsule filling in regulated pharmaceutical and nutraceutical environments. Based on volumetric dosing principles using gravity-fed or pneumatically assisted powder/pellet metering, the system executes fully automated capsule separation, dosing, and sealing cycles without manual intervention. Its compact footprint enables integration into quality control laboratories, pilot-scale production suites, or R&D cleanrooms where space is constrained but regulatory adherence remains non-negotiable. The machine operates under a deterministic, PLC-driven control architecture that ensures cycle reproducibility and traceability—critical prerequisites for process validation and regulatory submissions under ICH Q5, Q7, and FDA 21 CFR Part 11 frameworks.
Key Features
- PLC-controlled automation with configurable cycle parameters (fill weight, tamping force, dwell time) via intuitive HMI interface
- Benchtop configuration optimized for ISO Class 7 (10,000) or higher cleanroom compatibility; no floor-mounting required
- Full product-contact pathway constructed from electropolished AISI 316 stainless steel to ensure corrosion resistance, cleanability, and compliance with USP and EP 3.1.1 material specifications
- Universal capsule size handling—from #00 (largest) to #4 (smallest)—via quick-change tooling kits with mechanical alignment verification
- Integrated vacuum manifold supporting dual-stage aspiration: primary vacuum (6 m³/h) for capsule body/cap separation and secondary high-flow suction (9 m³/h) for powder recovery and dust suppression
- Onboard air compressor (50 L/min @ 1.5 bar) eliminates dependency on facility compressed air lines, enhancing operational independence and reducing contamination risk from external sources
- Modular vacuum pump assembly with oil-free diaphragm technology, minimizing maintenance intervals and eliminating lubricant carryover into the fill zone
Sample Compatibility & Compliance
The AC-3000 accommodates free-flowing powders, granules, and low-viscosity gelling agents suitable for soft gelatin capsule (SGC) encapsulation—provided feed material exhibits consistent bulk density and particle size distribution (PSD) within Dv50 = 20–150 µm range. It is not intended for highly cohesive, hygroscopic, or fibrous materials requiring screw-fed or auger-based dosing. All mechanical and electrical subsystems conform to EN 61000-6-2 (EMC immunity) and EN 61000-6-4 (EMC emission) standards. The equipment bears CE marking per Machinery Directive 2006/42/EC and Low Voltage Directive 2014/35/EU. Design documentation includes GMP-relevant risk assessments (per ISO 14971), FAT/SAT protocols, and material traceability records for all wetted parts.
Software & Data Management
The embedded Siemens SIMATIC S7-1200 PLC provides deterministic real-time control with onboard data logging of cycle count, vacuum pressure profiles, motor current draw, and alarm history. Optional Ethernet/IP or PROFINET connectivity enables integration with MES systems (e.g., Siemens Opcenter, Werum PAS-X) for electronic batch record (EBR) synchronization. Audit trail functionality meets ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Raw log files are exportable in CSV format; no proprietary binary formats are used. Firmware updates follow change control procedures aligned with Annex 11 and PIC/S PI 011-3 requirements.
Applications
- Routine QC batch release testing of capsule content uniformity (USP )
- Pilot-scale formulation development for immediate-release and modified-release capsules
- Stability study sample preparation under ICH Q1–Q5 conditions
- GMP-compliant small-batch manufacturing for clinical trial materials (Phase I–II)
- Training platform for aseptic processing and capsule manufacturing SOPs
- Comparative dissolution method development requiring matched capsule geometry and fill mass
FAQ
Does the AC-3000 support weight-based feedback control during dosing?
No. Dosing is volumetric and calibrated per capsule size and powder density. For gravimetric verification, an external check-weigher (e.g., Mettler Toledo C3000) must be integrated downstream.
Is IQ/OQ documentation provided with the system?
Yes—standard delivery includes pre-executed Installation Qualification (IQ) templates and Operational Qualification (OQ) test scripts compliant with ASTM E2500-13 and ISPE Baseline Guide Vol. 5.
Can the machine be validated for use with potent compounds (OEL ≤ 10 µg/m³)?
Yes, when operated inside a contained isolator with HEPA-filtered exhaust and negative pressure differential. Additional engineering controls (e.g., glove ports, solvent-resistant seals) must be specified at order stage.
What maintenance intervals are recommended for the vacuum pump and gearbox?
Vacuum pump diaphragms: 12 months or 2,000 operating hours (whichever occurs first). Gearbox lubrication: 24 months or 4,000 hours; oil analysis recommended annually.
Is remote diagnostics supported?
Yes—via secure VPN-enabled web server (HTTPS) with role-based access control. Diagnostic logs include real-time sensor values, PLC memory dump, and event timestamps.
